Login to Apply

As a Lead CMC Chemist you will be responsible for supporting development, validation and regulatory submissions of APIs whilst ensuring compliance with industry and regulatory requirements. The role is a blend of hands-on chemistry, project management and supporting with regulatory submissions.

Client Details

The client are a leading API manufacturer based in Hertfordshire. They have a small but innovative team dedicated to producing high quality APIs.

Description

As a CMC Chemist you will:

Develop and optimise a range of processes inclusive of extraction, purification and formulation for APIs
Carry out development studies in a lab setting to evaluate parameters, scalabiltiy and robustness of processes
Develop and validate suitable analytical methods for analysis of extracts and APIs
Prepare and review CMC documentation including technical reports, batch records and regulatory dossiers
Provide technical expertise and data to support regulatory submissions

This role offers a hybrid working model, initially with 4 days on site per week.

Profile

To be successful you will have:

A degree or higher qualification in Chemistry, Pharmaceutical Sciences, or a related field.
Strong experience in CMC processes within the life science industry.
First-hand experience planning and delivering analytical methods and development studies
Comprehensive knowledge of regulatory requirements and guidelines inclusive of GMP.
Proven ability to manage multiple projects simultaneously.Job Offer

This is a fantastic opportunity to join a small yet leading business in the field taking ownership of CMC projects